The U.S. District Judge presiding over all federal Zofran birth defect lawsuits has rejected an attempt by the drug maker to have certain fraud-based claims dismissed, finding that sufficient allegations have been presented by the plaintiffs to proceed on the basis that the pregnancy warnings for the anti-nausea drug were false and misleading, and thus constitute fraud.

GlaxoSmithKline currently faces at least 364 product liability lawsuits brought by families nationwide over the alleged failure to adequately warn women and doctors about the potential side effects of Zofran during pregnancy, which has been linked to reports of children born with cleft palate, cleft lip, atrial septal defects, ventricular septal defects and other congenital malformations.

Given the similar questions of fact and law presented in the litigation, cases filed in U.S. District Courts nationwide have been centralized for coordinated pretrial proceedings before U.S. District Judge Dennis Saylor in the District of Massachusetts, to reduce duplicative discovery, avoid conflicting pretrial rulings from different courts, and to serve the convenience of the parties, witnesses and the judicial system.

In a memorandum and order (PDF) issued on April 24, Judge Saylor denied a motion filed by the drug maker to dismiss plaintiffs’ Zofran fraud claims. While Judge Saylor indicated that the plaintiffs’ allegations were inadequate to state a claim for fraud based on GlaxoSmithKline’s alleged marketing and advertising campaigns, and pointed out that there were no allegations that any specific representatives of the drug maker made a false statement to a prescribing physician, the court found that fraud allegations based on the product label were sufficiently particular to satisfy the requirements of federal rules.

“Here, the master complaints allege generally that plaintiffs and their physicians relied on the misrepresentation in the label in prescribing and ingesting Zofran and/or ondansetron,” according to the opinion. “In this context, at least, that is sufficient. Pharmaceutical product labeling is highly regulated, and its very purpose is to advise prescribing physicians, who may reasonably rely on the representations in such labeling. Whether a particular physician did, in fact, rely on the representations in the labeling is of course a question of fact that cannot be resolved on the pleadings.”

The order comes as general discovery continues in the litigation. As part of the coordinated MDL proceedings, it is expected that Judge Saylor will establish a bellwether process in the coming months, which will prepare a small group of cases for early trial dates to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the cases filed by families of children suffering from birth defects or malformations following Zofran exposure during pregnancy.

Zofran Pregnancy Risks

In the litigation, plaintiffs allege that GlaxoSmithKline knew or should have known about the Zofran pregnancy risks for years, yet failed to warn doctors or consumers against use of the drug to treat morning sickness.

As early as 2006, plaintiffs note that studies have found that Zofran crosses the placenta in significant amounts when taken by pregnant women, with Hong Kong researchers concluding that the “developmental significance of this drug exposure requires further investigation.”

In November 2011, a study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology concluded that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use. This may leave children with a severe facial deformity, which can occur when development of the fetus is impacted during the first trimester.

In August 2013, another study highlighted a potential risk of heart defects with Zofran, following a review of data involving more than 900,000 pregnancies in the Danish Medical Birth Registry. Researchers found that children may be two to four times more likely to suffer a septal defect, involving holes in the heart, following Zofran exposure.

Following pretrial proceedings and any bellwether trials, if the parties fail to reach Zofran settlements for children left with birth defects following exposure to the drug, GlaxoSmithKline may face hundreds of individual trials in U.S. District Courts throughout the country over the failure warn women and the medical community about the potential risk of birth defects linked to the anti-nausea drug.